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FDA Approves Obinutuzumab for Follicular Lymphoma

Dr. Richard Pazdur

Sandra Horning, MD

The FDA approved obinutuzumab (Gazyva) plus bendamustine followed by obinutuzumab alone for the treatment of patients with follicular lymphoma who were not responsive to a rituximab regimen, or who relapsed after rituximab-based therapy, according to Genentech, the manufacturer of the anti-CD20 agent.

The approval is based on the phase III GADOLIN study, in which obinutuzumab plus bendamustine followed by obinutuzumab reduced the risk of disease progression by 52% compared with bendamustine alone (HR = 0.48; 95% CI 0.34-0.68; P <.0001) in patients with follicular lymphoma who progressed on a rituximab-based treatment.

"People with follicular lymphoma whose disease returns or worsens despite treatment with a Rituxan-containing regimen need more options because the disease becomes more difficult to treat each time it comes back," said Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech. "Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death." Click here to read the full article at

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